摘要
目的:采用高分辨质谱及组学分析技术,从化学成分差异的角度对不同厂家藿香正气水的质量进行整体评价研究。方法:采用超高效液相色谱-四极杆飞行时间串联质谱(UPLC-Q TOF MS/MS),电喷雾离子化模式(正和负),采集9个厂家、54批次藿香正气水样品中MS^(E)数据。色谱柱为Waters ACQUITY UPLCBEH C_(18)(100 mm×2.1 mm, 1.7μm),柱温40℃,流动相为0.1%甲酸水溶液(A)-乙腈(B),流速0.4 mL·min^(-1),进样体积1μL;采集质量范围为m/z 50~1 200。运用组学分析软件对获得的大量数据进行处理,并使用主成分分析(PCA)方法,对不同厂家藿香正气水的质量进行了比较研究,对样品中部分具有显著性差异的成分进行了鉴定与归属,并采用HPLC法对样品中橙皮苷、芸香柚皮苷和甘草酸的含量进行了测定与比较。结果:PCA结果表明,不同厂家藿香正气水的质量差异显著,对样品中具有显著性差异的橙皮苷、芸香柚皮苷和甘草酸进行了鉴定和归属,9个厂家样品中的橙皮苷含量相当,厂家H、I样品中芸香柚皮苷和甘草酸含量远低于其余厂家。结论:本研究从化学物质差异的角度,应用UPLC-Q TOF MS/MS技术结合PCA方法成功将9个不同厂家藿香正气水的质量进行了区分,并采用HPLC方法对部分组学分析结果进行了验证,为该产品的质量控制及质量标准的完善提供了依据。该方法为以后开展多组分复杂体系中成药的质量评价提供了思路和方法。
Objective:To evaluate the quality of Huoxiang Zhengqi tincture from different manufacturers by high-resolution mass spectrometry and omics analysis technology from the perspective of chemical composition difference. Methods: The MS^(E)data of 54 batches of the samples from 9 manufacturers were collected by ultraperformance liquid chromatography coupled with electrospray ionization/quadrupole-time of flight mass spectrometry(UPLC-Q TOF MS)(positive and negative). The mobile phase was 0.1% formic acid aqueous solution(A)-acetonitrile(B). The column temperature was 40 ℃. The flow rate was 0.4 mL·min^(-1). Injection volume was 1 μL. The mass range was m/z 50-1 200. The quality of Huoxiang Zhengqi tincture from different manufacturers was evaluated and compared, based on the principal component analysis(PCA) after the numerous rawdata obtained were processed by the omics analysis software. Some components with significant difference among the samples were identified and assigned. The contents of hesperidin, naringin and glycyrrhizic acid in the samples were determined and compared by HPLC-UV. Results: The difference existed significantly among the products from different manufacturers. The content of hesperidin was similar among all the manufacturers, but the content of naringin and glycyrrhizic acid was very low in samples from manufacturer H and manufacturer I compared with those fromother manufacturers. Conclusion: From the perspective of chemical composition, the difference in the quality of Huoxiang Zhengqi tincture from 9 manufacturers is distinguished clearly based on the technology of UPLC-Q TOF MS and PCA. The result of PCA analysis is also verified by HPLC method. It provids the basis for quality control and quality standard improvement of Huoxiang Zhengqi tincture.This technology is helpful to solve the problem of quality evaluation of Chinese patent medicine with multi-component complex systems.
作者
郑新元
王静
张茉
王静
周军
王杰
ZHENG Xin-yuan;WANG Jing;ZHANG Mo;WANG Jing;ZHOU Jun;WANG Jie(Tianjin Institute for Drug and Control,Tianjin 300070,China;Waters Technologies(Bejing)Lud,Bejing 100025,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2022年第7期1266-1277,共12页
Chinese Journal of Pharmaceutical Analysis
基金
2017年国家市场监督管理总局政策研究课题
天津市科技计划项目(19YFZCSY00170)
天津市市场监督管理委员会课题(2018-W10)。
